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Hormone Therapy

LUM-201 for Growth Hormone Deficiency (OraGrowtH211 Trial)

Phase 2

Waitlist Available

Research Sponsored by Lumos Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to month 36

Awards & highlights

OraGrowtH211 Trial Summary

This trial looks at the safety and effectiveness of a drug to help kids with growth hormone deficiency.

Who is the study for?

This trial is for children with Idiopathic Pediatric Growth Hormone Deficiency who have already been part of a previous LUM-201 study. They must have completed at least 12 months in that study and be cleared to continue treatment. Children with conditions that add risk or those on certain long-term medications affecting LUM-201 metabolism cannot participate.Check my eligibility

What is being tested?

The trial is testing the long-term safety of a drug called LUM-201 in children with growth hormone deficiency. It will also look at how the body responds to the drug over time and its effectiveness in promoting growth.See study design

What are the potential side effects?

While specific side effects are not listed, they may include reactions related to growth hormone treatments such as joint pain, headaches, muscle pain, and issues with insulin resistance. Long-term safety monitoring aims to identify any additional side effects.

OraGrowtH211 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent adverse events

Secondary outcome measures

Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201

Change in Bone Age (BA)

Change in Weight SDS

+3 more

OraGrowtH211 Trial Design

1Treatment groups

Experimental Treatment

Group I: LUM-201 (1.6 mg/kg/day)Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lumos PharmaLead Sponsor

4 Previous Clinical Trials

122 Total Patients Enrolled

3 Trials studying Human Growth Hormone Deficiency

122 Patients Enrolled for Human Growth Hormone Deficiency

Media Library

LUM-201 (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05796440 — Phase 2

Human Growth Hormone Deficiency Research Study Groups: LUM-201 (1.6 mg/kg/day)

Human Growth Hormone Deficiency Clinical Trial 2023: LUM-201 Highlights & Side Effects. Trial Name: NCT05796440 — Phase 2

LUM-201 (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796440 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors able to participate in the clinical trial?

"The requirements for applicants of this trial are that they must lie between the age range of 5 to 14. Moreover, there exists 24 studies involving minors and 25 trials targeting geriatrics."

Answered by AI

Is the daily dosage of LUM-201 (1.6 mg/kg) recognized by government health regulators?

"Our team has assigned LUM-201 (1.6 mg/kg/day) a score of 2 on the safety scale since there is evidence of security but none demonstrating efficacy, as this trial falls into Phase 2."

Answered by AI

Is the recruitment of participants still in progress for this trial?

"Per the information on clinicaltrials.gov, this experiment is not actively recruiting participants as of August 9th 2023 - when it was last updated. The study opened in early August and has since been inactive. However, there are 52 other trials that are currently enrolling patients into their studies."

Answered by AI

To what demographic does this research opportunity extend?

"This trial requires 60 minor participants aged between 5 and 14 who are diagnosed with human growth hormone deficiency. Furthermore, these minors must have already participated in a pediatric LUM-201 GHD study up to the 12 month visit and meet all other enrollment criteria for continuation of treatment. In addition, parental or guardian consent as well as patient assent is required before participation can occur."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

2023. "A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796440.

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